(162 days)
Not Found
Not Found
No
The summary describes a dental composite material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a composite material used for core build-ups and as a restorative filling material in dentistry, which falls under restorative or reconstructive dentistry rather than direct therapeutic treatment of a disease or condition.
No
The description states the device is a "light-activated composite material designed for core build-ups" and material for "restorative filling." It is used for treatment, not for diagnosing any condition.
No
The device description clearly states it is a "translucent, light activated composite material" and a "line extension to the current two-component dual curable Build-If FR core material." This describes a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for core build-ups and as a final restorative filling material in teeth. This is a direct treatment or restoration applied to the patient's body.
- Device Description: The description details the material composition and physical properties of a dental composite. It does not describe a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a dental material used for restorative purposes directly on the tooth.
N/A
Intended Use / Indications for Use
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.
Product codes
EBF
Device Description
Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Clearfil Photo Core, Kuraray Medical Inc.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are written in a smaller, sans-serif font. The logo is black and white.
OCT 8.0 2009
Section III - 510(k) Summary of Safety and Effectiveness
Submitter:
Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7602 - Phone (714) 516-7472 - Facsimile Wendy Garman - Contact Person
May 2009 Date Summary Prepared:
. Device Name:
- · Trade Name Build-It Light Cure
- · Common Name Dental Composite Restorative Material
- · Classification Name Tooth Shade Resin Material, per 21 CFR § 872.3690
Devices for Which Substantial Equivalence is Claimed:
- · Clearfil Photo Core, Kuraray Medical Inc.
Device Description:
Build-It light Cure is a line extension to the current two-component dual curable Build-If FR core material. It is available in a translucent shade only. The depth of cure of the material is > 7 mm to facilitate the bulk is available in a tallslucein silade only. The depart of on the resin mixture and the fillers are immy. The combination of the material dalbarumborosilicate glasses with a little sodium fluoride. The cosonially the connecter of the material facilitates easy adaption to the tooth.
Intended Use of the Device:
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. I is usets Build-If Light Cure is a nailsluccin; agar actriated composited teeth, in combination with or without a dental v post. It may also be used as a final restorative filling material.
Substantial Equivalence:
Suild-It Light Cure is substantially equivalent to other legally marketed devices in the United States. Build-It Light Bulld-It Light Cure is substantary cquiratent to Clica regary an entrently marketed by Kuraray Medical Inc.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Pentron Clinical Technologies, LLC C/O Ms. Wendy Garman Director of Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867
OCT 3 0 2009
Re: K091512
Trade/Device Name: Build-It Light Cure Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: September 23, 2009 Received: September 30, 2009
Dear Ms. Garman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Ms. Garman
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
3
Indications for Use
510(k) Number (if known):
Device Name: Build-It Light Cure
Indications For Use:
Build-It Light Cure is a translucent, light activated composite material designed for core build ups. It is used as core-building material on vital teeth as well as on non-vital teeth, in combination with or without a dental post. It may also be used as a final restorative filling material.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
I
Kein Muluy
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K091512
Page 1 of 1